The U.S. Department of Health and Human Services (HHS) Defense Production Act (DPA) Title III Program recently issued a Request for Information (RFI) aimed at strengthening the domestic production of anti-microbial products. This initiative seeks input from industry to assess current capacities and capabilities in producing essential anti-microbials critical for public health and national defense. Here’s a breakdown of the RFI details and what interested parties need to know.
Overview of Solicitation
The RFI aims to gather insights into the Public Health Industrial Base (PHIB), focusing on domestic capabilities to produce and supply anti-microbials. The data collected will inform future investments under DPA Title III, an authority that empowers the government to incentivize domestic production of vital health resources.
Key Proposal Information
Respondents are encouraged to provide details on:
- Production Capabilities: Insights on precursors, key starting materials (KSMs), active pharmaceutical ingredients (APIs), and finished dosage forms (FDFs) are requested, especially for 27 priority medicines, including Amoxicillin, Cefepime, and Vancomycin.
- Manufacturing Readiness and Capacity: Information on production scale, bottlenecks, and the potential for expansion or modernization of existing facilities to support population-scale manufacturing.
- Supply Chain and Regulatory Compliance: Details on regulatory certifications (e.g., DMF, NDA), location of facilities, production equipment, and any challenges in meeting demand due to supply chain issues.
Additional Considerations
The RFI emphasizes the importance of solutions that align with HHS’s Title III mission of building long-term, sustainable U.S.-based manufacturing. Notably, all projects must comply with DPA’s domestic source requirements, focusing exclusively on U.S. and select allied nations’ capabilities. Respondents should also indicate preferences for contractual arrangements, such as Federal Acquisition Regulation (FAR)-based contracts or Other Transaction Agreements (OTAs).
Important Deadlines
- Clarifications: Questions are due by December 2, 2024, 10:00 AM ET.
- Submission Deadline: RFI responses must be submitted by December 9, 2024, 10:00 AM ET.
HHS’s DPA Title III Program encourages interested stakeholders to respond and help shape the future of domestic anti-microbial production to ensure a resilient public health infrastructure. This is a crucial opportunity for industry players to provide feedback that could influence national health and defense strategies.
If your company has considered applying for HHS funding, your federal funding journey starts here.
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